Cleared Traditional

Airway Mobilescope

K201300 · Olympus Medical Systems Corp. · Ear, Nose, Throat

Jan 2021

Decision

256d

Days

Class 2

Risk

About This 510(k) Submission

K201300 is an FDA 510(k) clearance for the Airway Mobilescope, a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by Olympus Medical Systems Corp. (Hachiochi-Shi, JP). The FDA issued a Cleared decision on January 26, 2021, 256 days after receiving the submission on May 15, 2020. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K201300 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2020
Decision Date	January 26, 2021
Days to Decision	256 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EOQ — Bronchoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).